Winfuran: Withdrawal of the marketing authorisation application
On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Winfuran (PDF/2.18 MB)Adopted
First published: 11/03/2014
Last updated: 11/03/2014
Withdrawal letter: Winfuran (PDF/49.82 KB)
First published: 24/01/2013
Last updated: 24/01/2013
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) (PDF/88.88 KB)
First published: 24/01/2014
Last updated: 24/01/2014
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').